Dynamic control of transcutaneous electrical nerve stimulation therapy using continuous sleep detection

Abstract

Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising: a housing; an application unit for providing mechanical coupling between the housing and the user's body; a stimulation unit for electrically stimulating at least one nerve of the user; a sensing unit for (i) sensing the user's body movement and body orientation to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing the sleep characteristics of the user during the “rest-in-bed” state; and a feedback unit for at least one of (i) providing the user with feedback in response to the analysis of the sleep characteristics of the user, and (ii) modifying the electrical stimulation provided to the user by the stimulation unit in response to the analysis of the sleep characteristics of the user; wherein the sleep characteristics comprise a likelihood measure of the user's sleep quality.

What is claimed is: 
     
       1. Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising:
 a housing; 
 an application unit for providing mechanical coupling between said housing and the user's body; 
 a stimulation unit for electrically stimulating at least one nerve of the user; 
 a sensing unit for (i) sensing the body movement and body orientation of the user to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing sleep characteristics of the user during said “rest-in-bed” state; and 
 a feedback unit for at least one of (i) providing the user with feedback in response to said analysis of said sleep characteristics of the user, and (ii) modifying the electrical stimulation provided to the user by said stimulation unit in response to said analysis of said sleep characteristics of the user; 
 wherein said sleep characteristics comprise a likelihood measure of the sleep quality of the user. 
 
     
     
       2. Apparatus according to  claim 1  wherein said application unit is a flexible band. 
     
     
       3. Apparatus according to  claim 1  wherein said application unit determines whether said housing is mechanically coupled to the body of the user. 
     
     
       4. Apparatus according to  claim 3  wherein a mechanical element determines whether said housing is mechanically coupled to the user's body. 
     
     
       5. Apparatus according to  claim 4  wherein said mechanical element is a tension gauge. 
     
     
       6. Apparatus according to  claim 3  wherein an electrical element determines whether said housing is mechanically coupled to the body of the user. 
     
     
       7. Apparatus according to  claim 1  wherein the user is determined to be in said “out-of-bed” state when a body orientation angle exceeds a threshold. 
     
     
       8. Apparatus according to  claim 1  wherein the user is determined to be in said “out-of-bed” state when a body movement pattern matches a pattern for walking. 
     
     
       9. Apparatus according to  claim 1  wherein the user is determined to be in said “out-of-bed” state when a body orientation angle exceeds a threshold and when body movement pattern matches a pattern for stepping. 
     
     
       10. Apparatus according to  claim 1  wherein said sensing unit uses data from an electromechanical sensor. 
     
     
       11. Apparatus according to  claim 10  wherein the determination of whether said housing is mechanically coupled to the body of the user determines the usability of the data from said electromechanical sensor. 
     
     
       12. Apparatus according to  claim 10  wherein said electromechanical sensor is an accelerometer. 
     
     
       13. Apparatus according to  claim 10  wherein said electromechanical sensor is a gyroscope. 
     
     
       14. Apparatus according to  claim 10  wherein said electromechanical sensor comprises both an accelerometer and a gyroscope. 
     
     
       15. Apparatus according to  claim 10  wherein said sensing unit determines the body orientation angle of the user with an analysis unit operating on earth gravitational acceleration measurements from said electromechanical sensor. 
     
     
       16. Apparatus according to  claim 10  wherein said sensing unit determines a movement pattern of the user with an analysis unit operating on said data from said electromechanical sensor. 
     
     
       17. Apparatus according to  claim 16  wherein said movement pattern is determined to be a walking pattern when a processed feature of said data is determined to be stepping continuously for a period of time. 
     
     
       18. Apparatus according to  claim 17  wherein said processed feature is determined to be a stepping pattern when filtered components of the data from said electromechanical sensor match a target temporal pattern. 
     
     
       19. Apparatus according to  claim 1  wherein said sleep characteristics for a time segment are determined based on at least one feature selected from the group consisting of (i) mean leg activity, (ii) mean leg elevation, (iii) leg rotation amount, and (iii) duration of the time segment. 
     
     
       20. Apparatus according to  claim 19  wherein analyzing said sleep characteristics comprises utilizing a Bayesian classifier to compare at least one feature to a predetermined classifier threshold. 
     
     
       21. Apparatus according to  claim 20  wherein said predetermined classifier threshold is a function of the time elapsed from the onset of said “rest-in-bed” state. 
     
     
       22. Apparatus according to  claim 20  wherein said predetermined classifier threshold is a function of the health profile of the user. 
     
     
       23. Apparatus according to  claim 20  wherein said predetermined classifier threshold is a function of past sleep characteristics of the user. 
     
     
       24. Apparatus according to  claim 20  wherein said sleep characteristics of said time segment is determined to be “good” when the output of said Bayesian classifier exceeds said predetermined classifier threshold for said time segment. 
     
     
       25. Apparatus according to  claim 1  wherein said analysis of sleep characteristics determines sleep quality for a time segment. 
     
     
       26. Apparatus according to  claim 24  wherein said sleep quality is determined to be fragmented when the percentage of “good” sleep over said time segment is below a predetermined threshold. 
     
     
       27. Apparatus according to 25 wherein said time segment is at least one hour. 
     
     
       28. Apparatus according to  claim 24  wherein said feedback unit calculates the accumulated time during which sleep quality of the user is classified as “good”. 
     
     
       29. Apparatus according to  claim 28  wherein said feedback unit is activated when the said accumulated time exceeds a predetermined threshold. 
     
     
       30. Apparatus according to  claim 1  wherein said feedback unit provides feedback to the user via an alert delivered to the user through at least one selected from the group consisting of a smartphone and another connected device. 
     
     
       31. Apparatus according to  claim 1  wherein said feedback unit provides feedback to the user in the form of mechanical vibrations provided to the user. 
     
     
       32. Apparatus according to  claim 1  wherein said feedback unit provides feedback to the user in the form of electrical stimulation provided to the user. 
     
     
       33. Apparatus according to  claim 26  wherein said feedback unit modifies said electrical stimulation provided to the user when said sleep quality is not fragmented. 
     
     
       34. Apparatus according to  claim 33  wherein said electrical stimulation is modified to change stimulation intensity. 
     
     
       35. Apparatus according to  claim 33  wherein said electrical stimulation is modified to change stimulation frequency. 
     
     
       36. Apparatus according to  claim 33  wherein said electrical stimulation is modified to change the stimulation onset time. 
     
     
       37. Apparatus according to  claim 36  wherein said stimulation onset time change is to postpone a scheduled stimulation start time. 
     
     
       38. A method for applying transcutaneous electrical nerve stimulation to a user, said method comprising the steps of:
 applying a stimulation unit and a sensing unit to the body of the user; 
 using said stimulation unit to deliver electrical stimulation to the user so as to stimulate one or more nerves of the user; 
 analyzing electromechanical sensing data collected by said sensing unit in order to (i) determine the body orientation of the user, and (ii) quantify body activity levels so as to determine whether the user is in an “out-of-bed” state, wherein the user is awake, or a “rest-in-bed” state, wherein the user is at rest or asleep, whereby to determine the quality and duration of sleep of the user during the “rest-in-bed” state; and 
 modifying the electrical stimulation delivered by said stimulation unit based on said sleep quality and said duration of the sleep of the user during the “rest-in-bed” state. 
 
     
     
       39. Apparatus for monitoring the sleep patterns of a user, said apparatus comprising:
 a housing; 
 an application unit for providing mechanical coupling between said housing and the user's body; 
 a sensing unit carried by the housing for (i) sensing the body movement and body orientation of the user to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing sleep characteristics of the user during said “rest-in-bed” state; and 
 a feedback unit for providing the user with feedback in response to said analysis of said sleep characteristics of the user. 
 
     
     
       40. A method for monitoring the sleep patterns of a user, said method comprising of the steps of:
 applying a sensing unit and a feedback unit to the body of a user; 
 using said sensing unit to determine the body movement and body orientation of the user to (i) determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyze sleep characteristics of the user during said “rest-in-bed” state; and 
 providing the user with feedback via said feedback unit in response to said analysis of said sleep characteristics of the user. 
 
     
     
       41. Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising:
 a housing; 
 an application unit for providing mechanical coupling between said housing and the leg of a user; 
 a stimulation unit for electrically stimulating at least one nerve of the user; and 
 a sensing unit for (i) sensing the leg orientation and leg motion of the user to determine whether the user is in an “out-of-bed” state or a “rest-in-bed state”, wherein sensing the leg orientation of the user comprises determining the leg elevation and leg rotation of the user, and further wherein sensing the leg motion of the user comprises determining the net activity and leg movements of the user, and (ii) analyzing sleep characteristics of the user during said “rest-in-bed” state; and 
 a controller for modulating said stimulation unit based on said determinations of sleep characteristics made by said sensing unit. 
 
     
     
       42. Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising:
 a housing; 
 an application unit for providing mechanical coupling between said housing and the user's body; 
 a stimulation unit for electrically stimulating at least one nerve of the user; 
 a sensing unit for (i) sensing the body movement and body orientation of the user to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing sleep characteristics of the user during said “rest-in-bed” state; and 
 a feedback unit for at least one of (i) providing the user with feedback in response to said analysis of said sleep characteristics of the user, and (ii) modifying the electrical stimulation provided to the user by said stimulation unit in response to said analysis of said sleep characteristics of the user; 
 wherein said sleep characteristics comprise a likelihood measure of the sleep quality of the user; 
 wherein said sleep characteristics for a time segment are determined based on at least one feature selected from the group consisting of (i) mean leg activity, (ii) mean leg elevation, (iii) leg rotation amount, and (iii) duration of the time segment; 
 wherein analyzing said sleep characteristics comprises utilizing a Bayesian classifier to compare at least one feature to a predetermined classifier threshold; 
 wherein said predetermined classifier threshold is a function of at least one from the group consisting of the time elapsed from the onset of said “rest-in-bed” state, the health profile of the user, and past sleep characteristics of the user. 
 
     
     
       43. Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, said apparatus comprising:
 a housing; 
 an application unit for providing mechanical coupling between said housing and the user's body; 
 a stimulation unit for electrically stimulating at least one nerve of the user; 
 a sensing unit for (i) sensing the body movement and body orientation of the user to determine whether the user is in an “out-of-bed” state or a “rest-in-bed” state, and (ii) analyzing sleep characteristics of the user during said “rest-in-bed” state; and 
 a feedback unit for at least one of (i) providing the user with feedback in response to said analysis of said sleep characteristics of the user, and (ii) modifying the electrical stimulation provided to the user by said stimulation unit in response to said analysis of said sleep characteristics of the user; 
 wherein said sleep characteristics comprise a likelihood measure of the sleep quality of the user; 
 wherein said sleep characteristics for a time segment are determined based on at least one feature selected from the group consisting of (i) mean leg activity, (ii) mean leg elevation, (iii) leg rotation amount, and (iii) duration of the time segment; 
 wherein analyzing said sleep characteristics comprises utilizing a Bayesian classifier to compare at least one feature to a predetermined classifier threshold; 
 wherein said sleep characteristics of said time segment is determined to be “good” when the output of said Bayesian classifier exceeds said predetermined classifier threshold for said time segment. 
 
     
     
       44. Apparatus according to  claim 43  wherein said sleep quality is determined to be fragmented when the percentage of “good” sleep over said time segment is below a predetermined threshold. 
     
     
       45. Apparatus according to  claim 43  wherein said feedback unit calculates the accumulated time during which sleep quality of the user is classified as “good”. 
     
     
       46. Apparatus according to  claim 45  wherein said feedback unit is activated when the said accumulated time exceeds a predetermined threshold. 
     
     
       47. Apparatus according to  claim 44  wherein said feedback unit modifies said electrical stimulation provided to the user when said sleep quality is not fragmented. 
     
     
       48. Apparatus according to  claim 47  wherein said electrical stimulation is modified to change at least one from the group consisting of stimulation intensity, stimulation frequency and stimulation onset time. 
     
     
       49. Apparatus according to  claim 48  wherein said stimulation onset time change is to postpone a scheduled stimulation start time.